The Medicines and Healthcare Products Regulatory Agency (MHRA) published a guidance on "Medicines Pipeline Data" on 13 August, 2024 to enhance the transparency of the drug development process. This initiative provides early insights and details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
Medicines pipeline data refers to comprehensive information about drug development processes, including compounds in various stages of research, clinical trials, and regulatory approval.
This data provides insights into the future landscape of medications, highlighting what is currently being developed, when it might reach the market, and how it compares to existing treatments.
Pharmaceutical companies are encouraged to voluntarily submit data on medicines in development to the MHRA. The submission process involves providing information on new medicines that are expected to be licensed within the next two years. This includes details about the therapeutic area, the stage of development, and the anticipated timeline for market authorization.
The information to be submitted is filled in the spreadsheet template containing several fields about the expected and possible submission of applications and variations to the MHRA. It is intended that a picture of all incoming applications and new indications up to 5 years in advance of submission. Examples of data fields requested: Product Name, Active Ingredient, etc.
The process and template
Step 1 – Download the MS Excel template spreadsheet
Step 2 – Fill in with as much detail as possible/known
Step 3 – Return to the MHRA via email to presubmission@mhra.gov.uk
The MHRA will not hold stakeholders accountable based on pipeline data submitted since it is not intended to be concrete. As MHRA understands circumstances and plans change over time, the pre-submission team will keep track of the incoming pipeline data and request updates approximately every six months.
The medicines pipeline data helps the agency anticipate short to medium-term demand, enabling efficient resource allocation, consistent assessment timelines, and early identification of transformative technologies. This proactive planning ensures the agency can effectively evaluate the Quality, Safety, and Efficacy of medicines, improving the processing of applications.
For more details, visit the official UK MHRA Guidance on Medicines Pipeline Data.
Also, check this guidance "Guidance on Pre-submission Advice & Support" offers comprehensive pre-submission advice and support to help applicants navigate the regulatory process effectively. This guidance is designed to assist applicants in preparing high-quality submissions that meet regulatory requirements for medicines and medical devices.
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